FBS0701 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
284ダイアモンド・ブラックファン貧血3

284. ダイアモンド・ブラックファン貧血


臨床試験数 : 36 薬物数 : 95 - (DrugBank : 34) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2011-006322-25-IT
(EUCTR)
20/08/201203/09/2012Extension to the treatment of iron overload with chelation therapyA PHASE 3, OPEN-LABEL, MILTICENTRE, EXTENSION SAFETY AND TOLERABILITY STUDY FOR TRANSFUSIONALLY IRON OVERLOADED CHILDRE, ADOLISCENTS AND ADULTS USING FBS0701 (SSP-004184) - SPD602-301 (FBS0701 - CTP - 15) ADULT PATIENTS SUFFERING FROM IRON OVERLOAD OF TRANSFUSION-DEPENDENT DOCUMENTED, IN WHICH THE FOLLOWING PRIMARY DIAGNOSIS: ANEMIA HEREDITARY (EG sickle cell anemia), thalassemia and Diamond-Blackfan anemia
MedDRA version: 15.0;Level: LLT;Classification code 10065974;Term: Chronic iron overload;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: FBS0701 CAPSULE
Product Code: FBS0701/SSP004184
INN or Proposed INN: iron chelating agents
Product Name: FBS0701 CAPSULE
Product Code: FBS0701/SSP004184
INN or Proposed INN: IRON CHELATING AGENTS
Product Name: FBS0701 CAPSULE
Product Code: FBS0701/SSP004184
INN or Proposed INN: IRON CHELATING AGENTS
Product Name: FBS0701 CAPSULE
Product Code: FBS0701/SSP004184
INN or Proposed INN: IRON CHELATING AGENTS
Product Name: FBS0701 CAPSULE
Product Code: FBS0701
INN or Proposed INN: IRON CHELATING AGENTS
Product Name: FBS0701 CAPSULE
Product Code: FBS0701/SSP004184
INN or Proposed INN: IRON CHELATING AGENTS
FERROKIN BIOSCIENCES INC.NULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United States;United Kingdom;Italy
2EUCTR2011-005675-16-IT
(EUCTR)
15/05/201202/08/2012Treatment of chronic iron overload with a chelation therapy (FBS0701)A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two FBS0701 Doses in the Treatment of Chronic Iron Overload Requiring Chelation Therapy - FBS0701 in the treatment of chronic iron overload Patients with transfusional iron overload, with the following primary diagnosis:hereditary anemia (such as sickle cell disease),ß-thalassemia and Diamond Blackfan anemia;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: FBS0701 CAPSULE
Product Code: FBS0701
INN or Proposed INN: iron chelating agents
Product Name: FBS0701 CAPSULE
Product Code: FBS0701
INN or Proposed INN: Iron chelating agents
Product Name: FBS0701 CAPSULE
Product Code: FBS0701
INN or Proposed INN: Iron chelating agents
Product Name: FBS0701 CAPSULE
Product Code: FBS0701
INN or Proposed INN: iron chelating agents
Product Name: FBS0701 CAPSULE
Product Code: FBS0701
INN or Proposed INN: iron chelating agents
FERROKIN BIOSCIENCES INC.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Canada;Lebanon;Turkey;Italy
3EUCTR2010-019645-25-IT
(EUCTR)
04/08/201015/07/2010A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, and Pharmacodynamics of FBS0701 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy. - NDA Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, and Pharmacodynamics of FBS0701 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy. - ND Patients with transfusional iron overload due to hereditary anemias such as sickle cell disease, ß-thalassemia and Diamond-Blackfan anemia; acquired anemias such as Myelodysplastic Syndrome and other forms of bone marrow failure.Product Name: FBS0701 Capsule
Product Code: FBS0701
Product Name: FBS0701 Capsule
Product Code: FBS0701
Product Name: FBS0701 Capsule
Product Code: FBS0701
Product Name: FBS0701 Capsule
Product Code: FBS0701
FERROKIN BIOSCIENCES INC.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United Kingdom;Italy